With President Donald Trump retaking the White House and Republicans narrowly controlling both the House and Senate, healthcare marketers and publishers must prepare for anticipated legislative, regulatory, and procurement shifts. The CHC and 4A’s Government Relations team in partnership with advocacy experts brings you resources and guidance on what to expect and how to prepare. […]
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May 23, 2012 – At an FDA meeting held last week to explore more effective ways of including patient input in regulatory decisions regarding drug, device and biological products, the agency made it plain to patients, caregivers, patient advocates and patient advocacy groups that it wants patient perspectives to be included in the process. “This […]
Read moreSept. 16, 2011 – Trying to assess industry adherence with FDA advertising and promotion regulations is a tricky endeavor, according to an article posted today in Policy and Medicine. The article, “Study Shows Adherence to FDA Advertising Guidelines Are in the Eye of the Beholder,” states that although there currently is no “systemic assessment of […]
Read morePitts: BIO’s Call for Drastic Regulatory Change Is On Point June 27, 2011 — In a recent blog entry on DrugWonks.com, Peter Pitts commended BIO’s proposals to revamp the U.S. regulatory system for new treatments and therapies. Pitts mentions that BIO’s plans, as reported in BioCentury, include a progressive approval pathway for unmet condition therapies, […]
Read moreJune 16, 2011 – The Food and Drug Administration (FDA) should not mandate comparative effectiveness trials as part of the drug approval process, according to Scott Gottleib, a resident fellow with the American Enterprise Institute for Public Policy Research (AEI). Gottleib, a former FDA policy head, writes in AEI’s June issue of Health Policy Outlook […]
Read moreImmediate Guidance Slips Again May 9, 2011 – A recent notice in the Federal Register calling for comments on a series of Food and Drug Administration (FDA) studies to determine the most effective way of presenting risk information online indicates that the FDA is still a long way from developing significant new social media guidance. This status […]
Read moreApril 29, 2011 – In a Webinar yesterday, the U.S. Food and Drug Administration’s (FDA’s) Division of Drug Marketing, Advertising, and Communications (DDMAC) reminded medical marketers of its continued actions to enhance surveillance and monitoring of industry marketing by urging physicians and other healthcare professionals to report any potentially misleading marketing activities to DDMAC. Although the year-old program has resulted in only […]
Read moreAnnouncement Sends Ominous Signal to Industry Stakeholders March 18, 2011 — The Centers for Medicare & Medicaid Services (CMS) has given the industry its first glimpse of how it will implement the national registry of payments to doctors by sending a notice of a stakeholders’ call for next week, and the glimpse is not encouraging. Sounding like CMS wants more […]
Read moreMarch 11, 2011 — As the public debate over digital privacy continues, federal regulators on and off Capitol Hill are telling online marketers that now is the time to widely adopt strict self regulatory programs that enable Web users to opt-out of unwanted tracking and marketing. If not, marketers can expect legislation and/or regulation by […]
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